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3/15/2004

Advocacy Efforts Lead to Success on Bar Code Rule, Counterfeiting Initiative

ASHP’s advocacy efforts strongly influenced the Food and Drug Administration’s (FDA) recent announcement that it would require bar codes that include the National Drug Code (NDC) number on all hospital drug packaging and the agency’s new program to combat the prevalence of counterfeit drugs. 

ASHP waged a zealous campaign to influence the FDA’s stance on bar coding.  In testimony, letters, and meetings with agency officials, the Society made a compelling case for the use of machine-readable technology on drug packaging noting the wide availability of the technology and its patient safety benefits.  While the rule does not require that bar codes include a medication's lot number and expiration date, the FDA has assured ASHP that it will encourage manufacturers to include this information. 

As part of the FDA’s new Counterfeit Alert Network, ASHP and a variety of health professional organizations, industry trade organizations, and consumer groups will disseminate rapid alerts about counterfeiting incidents as well as strategies for identifying and reporting counterfeit drugs.  The Society recommended the use of such a network during its testimony at a FDA public meeting in October 2003. 

“Our success in influencing the FDA on these issues will greatly increase pharmacists’ ability to ensure the safety of patients in hospitals and health systems,” said ASHP Executive Vice President and CEO Henri R. Manasse, Jr., Ph.D., Sc.D.  “We are encouraged by the FDA’s efforts and will continue to work with agency officials as they seek solutions to other pressing matters.”